Pump assembly having a push valve for a penile prosthesis

ABSTRACT

According to an aspect, an inflatable penile prosthesis includes a fluid reservoir, an inflatable member, and a pump assembly. The pump assembly includes a pump bulb, a valve body, a push valve movably coupled to the valve body, a first fluid port, and a second fluid port. The push valve includes a movable valve element configured to move between an inflation position and a deflation position within a bore of the valve body. The movable valve element in the inflation position defines a fluid passageway through the bore to transfer fluid from the pump bulb to the second fluid port. The movable valve element, when moved to the deflation position, is configured to change the fluid passageway through the bore to transfer fluid from the second fluid port to the first fluid port such that the pump bulb is bypassed.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of, and claims priority to, U.S.patent application Ser. No. 16/687,073, filed on Nov. 18, 2019, entitled“PUMP ASSEMBLY HAVING A PUSH VALVE FOR A PENILE PROSTHESIS”, whichclaims priority to U.S. Patent Application No. 62/771,874, filed on Nov.27, 2018, entitled “PUMP ASSEMBLY HAVING A PUSH VALVE FOR A PENILEPROSTHESIS”, the disclosures of which are incorporated by referenceherein in their entirety.

TECHNICAL FIELD

This disclosure relates generally to bodily implants and morespecifically to bodily implants, such as a penile prosthesis thatincludes a pump assembly having a push valve to switch to a deflationmode.

BACKGROUND

One treatment for male erectile dysfunction is the implantation of apenile prosthesis that mechanically erects the penis. Some existingpenile prostheses include inflatable cylinders or members that can beinflated or deflated using a pump mechanism. The pump mechanism pullsfluid from a fluid reservoir and then transfers the fluid to theinflatable members. The pump mechanism may include a pump bulb and avalve body that includes one or more valve components. According to someexisting designs of inflatable penile prostheses, the complexity of thevalve components may cause the pump bulb to get struck in a collapsedstate, where the user may have to deform the valve block in order todislodge one or more valve components until fluid is able to pass aroundthem to refill the pump bulb.

SUMMARY

According to an aspect, an inflatable penile prosthesis includes a fluidreservoir configured to hold fluid, an inflatable member, and a pumpassembly configured to transfer the fluid between the fluid reservoirand the inflatable member. The pump assembly includes a pump bulb, avalve body, a push valve movably coupled to the valve body, a firstfluid port configured to be fluidly coupled to the fluid reservoir, anda second fluid port configured to be fluidly coupled to the fluidreservoir. The push valve includes a movable valve element configured tomove between an inflation position and a deflation position within abore of the valve body. The movable valve element in the inflationposition defines a fluid passageway through the bore to transfer fluidfrom the pump bulb to the second fluid port. The movable valve element,when moved to the deflation position, is configured to change the fluidpassageway through the bore to transfer fluid from the second fluid portto the first fluid port such that the pump bulb is bypassed.

According to some aspects, the inflatable penile prosthesis may includeone or more of the following features (or any combination thereof). Thepush valve may include a biasing member that biases the movable valveelement to the inflation position. The push valve may include a poppethaving a ring member. The movable valve element is configured to move tothe deflation position in a linear direction based on a singleinstantaneous push of the movable valve element by a user. The pumpassembly may include a button component that encloses a portion of themovable valve element when the movable valve element is in the inflationposition. The pump assembly may include a feedback component disposedbetween the button component and the movable valve element, where thefeedback component is configured to provide at least one of tactile orauditory feedback in response to the movable valve element being movedto the deflation position. A portion of the movable valve element mayextend outside the valve body when the movable valve element is in theinflation position, and the portion of the movable valve element may bedisposed inside the valve body when the movable valve element is in thedeflation position. The valve body may include a refill valve alignedwith the first fluid port, and the refill valve is configured totransfer fluid from the fluid reservoir to the pump bulb when themovable valve element is in the inflation position. The valve body mayinclude an inflation valve disposed in a fluid passageway between thepump bulb and the bore. The movable valve element may include a firstmovable member and a second movable member, where the first movablemember and the second movable member are configured to independentlymove with respect to each other. The valve body may include a refillvalve, and an inflation valve, where the refill valve and the inflationvalve are not used when the movable valve element is in the deflationposition.

According to an aspect, a pump assembly for an inflatable penileprosthesis includes a push valve movably coupled to a valve body, wherethe push valve includes a movable valve element configured to movebetween an inflation position and a deflation position within a bore ofthe valve body, and a plurality of fluid transfer ports including afirst fluid port configured to be fluidly coupled to a fluid reservoir,and a second fluid port configured to be fluidly coupled to aninflatable member. The movable valve element in the inflation positiondefines a fluid passageway through the bore to transfer fluid from apump bulb to the second fluid port. The movable valve element, whenmoved to the deflation position, is configured to change the fluidpassageway through the bore to transfer fluid from the second fluid portto the first fluid port such that the pump bulb is bypassed.

According to some aspects, the pump assembly may include any of theabove/below features (or any combination thereof). The movable valveelement may include a cylindrical unitary body having at least twosections with different diameters. The first fluid port includes a firsttubular member, and the second fluid port includes a second tubularmember and a third tubular member. The second tubular member isconfigured to be fluidly coupled to a first cylinder member of theinflatable member, and the third tubular member is configured to befluidly coupled to a second cylinder member of the inflatable member.The pump assembly includes a refill valve disposed within the valve bodyat a location that is aligned with a longitudinal axis of the firstfluid port, and an inflation valve disposed in a fluid passagewaybetween the bore and the pump bulb. The movable valve element isconfigured to move from the inflation position to the deflation positionalong an axis, where the axis is substantially orthogonal to thelongitudinal axis of the first fluid port. The pump assembly may includean anti-auto inflate valve disposed in a fluid passageway between thefirst fluid port and the second fluid port. A portion of the movablevalve element may extend outside the valve body when the movable valveelement is in the inflation position, and the pump assembly may furtherinclude a button component that encloses the portion of the movablevalve element, and a feedback component disposed between the buttoncomponent and an end portion of the movable valve element. The feedbackcomponent is configured to provide at least one of tactile or auditoryfeedback in response to the movable valve element being moved to thedeflation position.

According to an aspect, a method for controlling a direction of fluidthrough a pump assembly of an inflatable penile prosthesis includestransferring, by a pump assembly, fluid from a fluid reservoir to aninflatable member, including transferring the fluid from the fluidreservoir to a pump bulb via a refill valve, and transferring the fluidfrom the pump bulb to the inflatable member via an inflation valve and apush valve having a movable valve element. The method includes pushingthe movable valve element along an axis to a deflation position tochange a fluid passageway through a valve body of the pump assembly, andtransferring the fluid from the inflatable member to the fluid reservoirvia the push valve such that the fluid is not transferred through thepump bulb. In some examples, the refill valve and the inflation valveare not used to transfer the fluid from the inflation member to thefluid reservoir when the movable valve element is in the deflationposition.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an inflatable penile prosthesis having a pumpassembly with a push valve according to an aspect.

FIG. 2A illustrates an exterior of the pump assembly according to anaspect.

FIG. 2B illustrates a perspective of the pump assembly with the pushvalve in an inflation position according to an aspect.

FIG. 2C illustrates a perspective of the pump assembly with the pushvalve in a deflation position according to an aspect.

FIG. 2D illustrates a cross-section of a valve body of the pump assemblywith the push valve in the deflation position according to an aspect.

FIG. 2E illustrates a view of the valve body of the pump assembly withthe push valve in the deflation position according to an aspect.

FIG. 3A illustrates a perspective of an exterior of the pump assemblyaccording to an aspect.

FIG. 3B illustrates a perspective of the pump assembly with the pushvalve in the inflation position according to an aspect.

FIG. 3C illustrates a perspective of the pump assembly with the pushvalve in the deflation position according to an aspect.

FIG. 3D illustrates a perspective of a valve body of the pump assemblywith the push valve in the inflation position according to an aspect.

FIG. 3E illustrates a perspective of the valve body with the push valvein the deflation position according to an aspect.

FIG. 4A illustrates a perspective of the push valve according to anaspect.

FIG. 4B illustrates a perspective of the push valve in the inflationposition according to an aspect.

FIG. 4C illustrates a perspective of the push valve in the deflationposition according to an aspect.

FIG. 5A illustrates a perspective of an exterior of the pump assemblywith the push valve in the deflation position according to an aspect.

FIG. 5B illustrates a perspective of the pump assembly with the pushvalve in the inflation position according to an aspect.

FIG. 5C illustrates a perspective of the pump assembly with the pushvalve in the deflation position according to an aspect.

FIG. 5D illustrates a perspective of a valve body of the pump assemblywith the push valve in the deflation position according to an aspect.

FIG. 6A illustrates a feedback component as a dome structure accordingto an aspect.

FIG. 6B illustrates the feedback component disposed on an end surface ofa movable valve element according to an aspect.

FIG. 7 illustrates a flow chart depicting example operations of a methodof controlling a direction of fluid through a pump assembly of aninflatable penile prosthesis according to an aspect.

FIG. 8 schematically illustrates an inflatable penile prosthesis havinga pump assembly according to an aspect.

DETAILED DESCRIPTION

Detailed embodiments are disclosed herein. However, it is understoodthat the disclosed embodiments are merely examples, which may beembodied in various forms. Therefore, specific structural and functionaldetails disclosed herein are not to be interpreted as limiting, butmerely as a basis for the claims and as a representative basis forteaching one skilled in the art to variously employ the embodiments invirtually any appropriately detailed structure. Further, the terms andphrases used herein are not intended to be limiting, but to provide anunderstandable description of the present disclosure.

The terms “a” or “an,” as used herein, are defined as one or more thanone. The term “another,” as used herein, is defined as at least a secondor more. The terms “including” and/or “having”, as used herein, aredefined as comprising (i.e., open transition). The term “coupled” or“moveably coupled,” as used herein, is defined as connected, althoughnot necessarily directly and mechanically.

In general, the embodiments are directed to bodily implants. The termpatient or user may hereafter be used for a person who benefits from themedical device or the methods disclosed in the present disclosure. Forexample, the patient can be a person whose body is implanted with themedical device or the method disclosed for operating the medical deviceby the present disclosure.

FIG. 1 illustrates an inflatable penile prosthesis 100 including a fluidreservoir 102, an inflatable member 104, and a pump assembly 106configured to transfer fluid between the fluid reservoir 102 and theinflatable member 104 according to an aspect. The inflatable member 104may be implanted into the corpus cavernosae of the user, the fluidreservoir 102 may be implanted in the abdomen or pelvic cavity of theuser (e.g., the fluid reservoir 102 may be implanted in the lowerportion of the user's abdominal cavity or the upper portion of theuser's pelvic cavity), and the pump assembly 106 may be implanted in thescrotum of the user.

The pump assembly 106 includes a pump bulb 108, a valve body 110, a pushvalve 124 movably coupled to the valve body 110, a first fluid port 114fluidly coupled to the fluid reservoir 102 (via a first conduitconnector 103), and a second fluid port 115 fluidly coupled to theinflatable member 104 (via a second conduit connector 105). The firstfluid port 114 and the second fluid port 115 may extend from an endportion of the valve body 110. In some examples, the fluid transferports are disposed on (or defined by) a tube adaptor (e.g., a tripletube adaptor) that is separate from the valve body 110, and the tubeadaptor is coupled to the valve body 110. In some examples, the firstfluid port 114 includes an elongated tubular member defining a cavity.In some examples, the second fluid port 115 includes two separateelongated tubular members (e.g., one tubular member being fluidlycoupled to a first cylinder member of the inflatable member 104 andanother tubular member being fluidly coupled to a second cylinder memberof the inflatable member 104).

The push valve 124 is configured to move from an inflation position to adeflation position along an axis 121 within a bore of the valve body 110when pressed by a user in order to control the direction of the fluidthrough the fluid passageways of the valve body 110. The push valve 124includes a movable valve element 140 and a biasing member 144 thatbiases the movable valve element 140 to the inflation position. In someexamples, the movable valve element 140 is configured to move to thedeflation position in a linear direction based on a single instantaneouspush of the movable valve element 140 by a user. The pump assembly 106includes a button component 112 that encloses a portion of the movablevalve element 140 when the movable valve element 140 is in the inflationposition. The button component 112 may be a flexible button-shapedmaterial that extends over the movable valve element 140.

In some examples, the movable valve element 140 includes a directionalcontrol valve. In some examples, the movable valve element 140 includesan elongated cylindrical body having at least two sections withdifferent sizes. In some examples, the movable valve element 140includes one or more ring members (e.g., annular rings or retainerrings). In some examples, the biasing member 144 includes a spring. Insome examples, the movable valve element 140 includes a single unitarybody (e.g., a single cylindrical member). In some examples, the movablevalve element 140 includes a two-piece member (e.g., first and secondmovable members that are concentrically aligned and move independentlyof each other).

The design of the push valve 124 may reduce (or eliminate) thepossibility for the pump bulb 108 to get stuck in a collapsed state evenif the first squeeze to switch from the deflation mode to the inflationmode does not successfully move the movable valve element 140 to theinflation position. When the movable valve element 140 is in theinflation position, the inflatable penile prosthesis 100 is in aninflation mode (or inflation cycle). When the movable valve element 140is in the deflation position, the inflatable penile prosthesis 100 is ina deflation mode (or deflation cycle). In some examples, a single,instantaneous push of the movable valve element 140 transfers theinflatable penile prosthesis 100 to the deflation position (e.g., asopposed to pressing and holding the movable valve element 140 for acertain predetermined time). In some examples, movement of the movablevalve element 140 to the deflation position causes a fluid pathway toopen between the second fluid port 115 and the first fluid port 114 suchthat fluid can be transferred from the inflatable member 104 to thefluid reservoir 102 via the pump assembly 106 in a manner that bypassesthe pump bulb 108.

In contrast, in the inflation mode, the pump bulb 108 is used totransfer fluid from the fluid reservoir 102 to the inflatable member104. For example, the user may depress (or squeeze) the pump bulb 108and then release the pump bulb 108, and then repeat these operationsuntil the desired rigidity is achieved in the inflatable member 104. Therelease of the pump bulb 108 creates a suction force that pulls fluidfrom the fluid reservoir 102 to the pump bulb 108, and the depression ofthe pump bulb 108 expels the fluid from the pump bulb 108 to theinflatable member 104. In some examples, in the inflation mode, thevalve body 110 provides an optimized fluid passageway via the push valve124 that may decrease the pressure drop across the push valve 124 forfaster inflate time and/or decrease the fluid resistance therebyrequiring less pump bulb squeeze force to inflate.

The pump bulb 108 may be a flexible member defining a cavity. The pumpbulb 108 is coupled to and extends from the valve body 110. In someexamples, the pump bulb 108 extends from the valve body 110 in adirection that is opposite to the direction in which the first fluidport 114 and the second fluid port 115 extend from the valve body 110(e.g., located on opposite ends of the valve body 110). The pump bulb108 may be a squeeze pump. In some examples, the pump bulb 108 includesribbing or dimples to aid the user in gripping the pump bulb 108. Asindicated above, the pump bulb 108 may use suction and pressure to movethe fluid in and out of the cavity of the pump bulb 108 in the inflationmode. For example, the user may depress or squeeze the pump bulb 108 toexpel the fluid out of the cavity, and, when the flexible member returnsto its original shape, the resulting suction pushes the fluid into thecavity of the pump bulb 108. In some examples, the pump bulb 108 mayhave a bulb spring rate that is designed to refill the pump bulb 108 ina selected time frame.

The valve body 110 defines one or more fluid passageways through thevalve body 110. The valve body 110 includes valve components disposedwithin the fluid passageways to control the flow of the fluid throughthe valve body 110 in the inflation mode and the deflation mode. In someexamples, the valve body 110 includes a block of material that definesthe fluid passageways and encloses the valve components. In someexamples, the valve body 110 includes a silicone material. In someexamples, the valve body 110 may be molded from a silicone materialhaving a medium durometer value. In some examples, the pump assembly 106includes an outer protective casing that is disposed over the valve body110. In some examples, the outer protective casing has a material (e.g.,a polymer material) that is different from the valve body 110. In someexamples, the outer protective casing includes one or more tactilefeatures that help the user locate the valve body 110 (in order tolocate the push valve 124). In some examples, the tactile featuresinclude protruded portions, ridges, grooves, bumps, and/or depressions.

The valve body 110 includes a refill valve 120 and an inflation valve122. In some examples, the valve body 110 includes an anti-auto inflatevalve. The refill valve 120 may be used when the pump bulb 108 isrefilled. The refill valve 120 is not used in the deflation mode. Insome examples, the refill valve 120 is a one-way valve. In someexamples, the refill valve 120 is disposed in a fluid passageway withinthe valve body 110 between the first fluid port 114 and the pump bulb108. In some examples, the fluid passageway having the refill valve 120that extends between the first fluid port 114 and the pump bulb 108 isused only for refilling the pump bulb 108 (e.g., a separated fluidpathway), which may decrease bulb refill time (e.g., deceases the waittime between squeezes). In some examples, the refill valve 120 isfluidly coupled to the bore (where the push valve 124 moves within) andthe pump bulb 108.

In some examples, the refill valve 120 is aligned with the first fluidport 114. For example, the refill valve 120 may have an inlet and anoutlet, where fluid enters the inlet from the first fluid port 114 andexits the outlet to the pump bulb 108. The first fluid port 114 maydefine a longitudinal axis 119 that extends along the fluid pathway(e.g., between the inlet and the outlet) of the refill valve 120. Insome examples, the longitudinal axis 119 is orthogonal to the axis 121.The alignment of the refill valve 120 with the first fluid port 114 mayminimize fluid pathway tortuosity, and/or decrease pressure drop acrossthe refill valve 120. In some examples, the refill valve 120 includes afloating check ball with fluting (which may increase or maximize fluidvelocity across the refill valve 120). In some examples, the refillvalve 120 includes a biasing member that biases the refill valve 120 toa sealing position. In some examples, the biasing member includes aspring. In some examples, the refill valve 120 does not include abiasing member.

The inflation valve 122 may be disposed within a fluid passagewaybetween the pump bulb 108 and the push valve 124. The inflation valve122 may be used during the inflation of the inflatable member 104 (e.g.,when the fluid is transferred from the pump bulb 108 to the inflatablemember 104). The inflation valve 122 is not used during the deflationmode. In some examples, the inflation valve 122 is a one-way valve. Insome examples, the inflation valve 122 includes a check ball and abiasing member. The biasing member may bias the check ball to a sealingposition. In some examples, the biasing member includes a spring.

In the inflation position (and when the user is operating the pump bulb108), the fluid may flow from the first fluid port 114 (from the fluidreservoir 102) to the pump bulb 108 via the refill valve 120, and fromthe pump bulb 108 to the second fluid port 115 via the inflation valve122 and the push valve 124 (and then to the inflatable member 104). Inresponse to the movable valve element 140 being pressed to the deflationposition, the position in the movable valve element 140 within the boreof the valve body 110 may open a fluid passageway in the valve body 110to transfer fluid from the inflatable member 104 to the fluid reservoir102 that bypasses the pump bulb 108. For example, the movable valveelement 140, when moved to the deflation position, is configured tochange the fluid passageway through the bore to transfer fluid from thesecond fluid port 115 to the first fluid port 114 such that the pumpbulb 108 is bypassed. In some examples, due to the pressure inside ofthe inflatable member 104, some of the fluid may be automaticallytransferred from the inflation member 104 to the fluid reservoir 102 viathe pump assembly 106, and then the user may squeeze the inflatablemember 104 to transfer some of the remaining fluid in the inflatablemember 104.

In some examples, the pump assembly 106 includes a feedback componentdisposed between the button component 112 and the movable valve element140. The feedback component is configured to provide at least one oftactile or auditory feedback in response to the activation of themovable valve element 140 being moved to the deflation position. Forexample, when the movable valve element 140 is pressed, the feedbackcomponent may provide a sound and/or tactile feeling that the inflatablepenile prosthesis 100 has entered the deflation mode. In some examples,the feedback component includes a dome component.

Each of the first conduit connector 103 and the second conduit connector105 may define a lumen configured to transfer the fluid to and from thepump assembly 106. The first conduit connector 103 may be coupled to thepump assembly 106 and the fluid reservoir 102 such that fluid can betransferred between the pump assembly 106 and the fluid reservoir 102via the first conduit connector 103. For example, the first conduitconnector 103 may define a first lumen configured to transfer fluidbetween the pump assembly 106 and the fluid reservoir 102. The firstconduit connector 103 may include a single or multiple tube members fortransferring the fluid between the pump assembly 106 and the fluidreservoir 102.

The second conduit connector 105 may be coupled to the pump assembly 106and the inflatable member 104 such that fluid can be transferred betweenthe pump assembly 106 and the inflatable member 104 via the secondconduit connector 105. For example, the second conduit connector 105 maydefine a second lumen configured to transfer fluid between the pumpassembly 106 and the inflatable member 104. The second conduit connector105 may include a single or multiple tube members for transferring thefluid between the pump assembly 106 and the inflatable member 104. Insome examples, the first conduit connector 103 and the second conduitconnector 105 may include a silicone rubber material. In some examples,the pump assembly 106 may be directly connected to the fluid reservoir102.

The inflatable member 104 may be capable of expanding upon the injectionof fluid into a cavity of the inflatable member 104. For instance, uponinjection of the fluid into the inflatable member 104, the inflatablemember 104 may increase its length and/or width, as well as increase itsrigidity. In some examples, the inflatable member 104 may include a pairof inflatable cylinders or at least two cylinders, e.g., a firstcylinder member and a second cylinder member. The volumetric capacity ofthe inflatable member 104 may depend on the size of the inflatablecylinders. In some examples, the volume of fluid in each cylinder mayvary from about 10 milliliters in smaller cylinders and to about 50milliliters in larger sizes. In some examples, the first cylinder membermay be larger than the second cylinder member. In other examples, thefirst cylinder member may have the same size as the second cylindermember.

The fluid reservoir 102 may include a container having an internalchamber configured to hold or house fluid that is used to inflate theinflatable member 104. The volumetric capacity of the fluid reservoir102 may vary depending on the size of the inflatable penile prosthesis100. In some examples, the volumetric capacity of the fluid reservoir102 may be 3 to 150 cubic centimeters. In some examples, the fluidreservoir 102 is constructed from the same material as the inflatablemember 104. In other examples, the fluid reservoir 102 is constructedfrom a different material than the inflatable member 104. In someexamples, the fluid reservoir 102 contains a larger volume of fluid thanthe inflatable member 104.

FIGS. 2A through 2E illustrate various perspectives of a pump assembly206 having a push valve 224 configured to move from an inflationposition to a deflation position to open a fluid passageway thattransfers fluid from an inflatable member to a fluid reservoir in amanner that bypasses a pump bulb 208. For example, a user may push thepush valve 224 to place the penile prosthesis in a deflation mode. Inthe inflation position, the pump assembly 206 transfers fluid from thefluid reservoir to the inflatable member via the pump bulb 208. However,in the deflation position, the pump assembly 206 transfers fluid fromthe inflatable member to the fluid reservoir that bypasses the pump bulb208. In some examples, the push valve 224 is a switching valve. In someexamples, the pump assembly 206 is an example of the pump assembly 106of FIG. 1, and may include any of the features discussed with referenceto the inflatable penile prosthesis 100 of FIG. 1. Also, the pumpassembly 106 of FIG. 1 may include any of the features with respect tothe pump assembly 206 of FIGS. 2A though 2E.

FIG. 2A illustrates an exterior of the pump assembly 206 according to anaspect. FIG. 2B illustrates a perspective of the pump assembly 206 withthe push valve 224 in an inflation position according to an aspect. FIG.2C illustrates a perspective of the pump assembly 206 with the pushvalve 224 in a deflation position according to an aspect. FIG. 2Dillustrates a cross-section of a valve body 210 of the pump assembly 206with the push valve 224 in the deflation position according to anaspect. FIG. 2E illustrates a view of the valve body 210 of the pumpassembly 206 with the push valve 224 in the deflation position accordingto an aspect.

The pump assembly 206 includes a pump bulb 208, the valve body 210, thepush valve 224, a button component 212, and fluid transfer ports such asa first cylinder fluid port 213, a second cylinder fluid port 215, and afluid reservoir port 214. The fluid reservoir port 214 is configured tobe connected to the first conduit connector 103 of FIG. 1, and the firstcylinder fluid port 213 and the second cylinder fluid port 215 areconfigured to be connected to the second conduit connector 105 ofFIG. 1. The first cylinder fluid port 213 includes a first tubularmember defining a cavity. The second cylinder fluid port 215 includes asecond tubular member defining a cavity. The fluid reservoir port 214includes a third tubular member defining a cavity. In some examples, thefirst tubular member, the second tubular member, and the third tubularmember are disposed parallel to each other.

In some examples, the pump assembly 206 includes a tube adaptor 250. Insome examples, the tube adaptor 250 is a triple tube adaptor. The tubeadaptor 250 may be a unitary body (e.g., a single piece of material)that defines the first cylinder fluid port 213, the second cylinderfluid port 215, and the fluid reservoir port 214. For example, the tubeadaptor 250 may be manufactured separately from the valve body 210, butcoupled together during the assembly of the pump assembly 206. The tubeadaptor 250 is coupled to the valve body 210. In some examples, the tubeadaptor 250 is coupled to the valve body 210 using an interference fit.In some examples, the tube adaptor 250 is coupled to the valve body 210using an adhesive material and/or one or more fasteners.

The pump bulb 208 may extend from a first end portion 216 of the valvebody 210, and the fluid transfer ports may extend from a second endportion 218 of the valve body 210. The valve body 210 includes a sidesurface 217 that extends on one side of the valve body 210 between thefirst end portion 216 and the second end portion 218. The buttoncomponent 212 may extend from the side surface 217 and cover the pushvalve 224. A user may press the button component 212 to move the pushvalve 224 to the deflation position. In some examples, a singleinstantaneous push of the push valve 224 causes the push valve 224 tomove to the deflation position (and stay in the deflation position). Forexample, the user may not need to hold the push valve 224 for apredetermined period of time in order to move the push valve 224 to thedeflation position.

The valve body 210 includes passageways and valve components. The valvebody 210 may include a silicone material. For example, the valve body210 may be molded from a silicone material having a medium durometervalue. The valve body 210 includes the push valve 224, a refill valve220, an inflation valve 222, and an anti-auto inflate valve 230. Theanti-auto inflate valve 230 is shown with respect to FIG. 2D.

The push valve 224 includes a movable valve element 240 and a biasingmember 244 that biases the movable valve element 240 to the inflationposition (as shown in FIG. 2B). The button component 212 may be aflexible button-shaped material that extends over the movable valveelement 240. In some examples, the button component 212 may beconsidered a portion of the valve body's housing extends from the sidesurface 217 of the valve body 210. The biasing member 244 is biased toits elongated length, and, upon depression of movable valve element 240,the biasing member 244 compresses to a shorter length (or compressedstate). In some examples, the biasing member 244 includes a spring. Insome examples, the movable valve element 240 includes an elongatedcylindrical valve member. In some examples, the movable valve element240 includes a poppet. In some examples, the movable valve element 240includes a directional control valve. The movable valve element 240includes a first end portion 243, a ring member 242, and a second endportion 245. The ring member 242 may be a circular portion that extendsaround a portion of the shaft of the movable valve element 240. In someexamples, the ring member 242 includes an annular ring. In someexamples, the ring member 242 includes a retainer ring. The ring member242 is disposed on the movable valve element 240 at a location betweenthe first end portion 243 and the second end portion 245. In someexamples, the first end portion 243 includes a ring member. In someexamples, the second end portion 245 includes a ring member. In someexamples, the second end portion 245 has a size (e.g., diameter) smallerthan a size (e.g., diameter) of the first end portion 243. In someexamples, the first end portion 245 has a length (e.g., extending alongan axis 221) longer than a length (e.g., extending along the axis 221)of the second end portion 245. In some examples, the push valve 224 (orthe valve body 210 in general) includes a directional control valve.

The movable valve element 240 (or a portion thereof) is movable within amain bore 225 defined by the valve body 210. For example, in theinflation position, the first end portion 243 of the movable valveelement 240 extends from the side surface 217 (but is covered by thebutton component 212). In some examples, the main bore 225 is acylindrical cavity. The user may press the movable valve element 240 inthe main bore 225 along the axis 221 to the deflation position (as shownin FIGS. 2C through 2E). In some examples, the button component 212 thenflexes back to its original shape while the movable valve element 240remains in the deflation position. In the deflation position, the edgeof the second end portion 245 of the movable valve element 240 may bedisposed adjacent to (or contact) a protrusion extending from the end ofthe main bore 225 with the biasing member 244 being compressed. In someexamples, in the deflation position, the first end portion 243 of themovable valve element 240 is disposed within the valve body 210 (orsubstantially aligned with the side surface 217 of the valve body 210).

The pressure in the inflatable member may hold the movable valve element240 in the deflation position (e.g. cylinder pressure seats the pushvalve 224). In some examples, the main bore 225 may include one or moreprotrusions that contact the ring member 242 (and/or another portion ofthe movable valve element 240) to hold the movable valve element 240 inthe deflation position (e.g., preventing the biasing member 244 frompushing the movable valve element 240 to the inflation position). Inorder to switch to the inflation mode, the user may squeeze the pumpbulb 208 and the resulting pressure causes the movable valve element 240to move back to the inflation position. For example, as shown in FIG.2E, the portion of the main bore 225 disposed between the ring member242 and the end of the main bore 225 defines an activation forcepressure area 247. When the user squeezes the pump bulb 208, pressureinside of the activation force pressure area 247 increases, which forcesthe movable valve element 240 to switch to the inflation position.

The anti-auto inflate valve 230 is disposed within a post area 246 ofthe valve body 210. The post area 246 may be considered a refill andanti-auto inflate post area. For example, the post area 246 is a fluidpassageway area that transfers fluid from the fluid reservoir port 214to refill the pump bulb 208 (in the inflation mode) and also transfersfluid to the fluid reservoir port 214 (in the deflation mode). In someexamples, the anti-auto inflate valve 230 includes a check ball. In someexamples, the anti-auto inflate valve 230 includes a check ball and abiasing member (e.g., a spring).

The refill valve 220 is disposed in a fluid passageway within the valvebody 210 between the fluid reservoir port 214 and the pump bulb 208. Therefill valve 220 is used to transfer fluid in the inflation mode, butnot used to transfer fluid in the deflation mode. In some examples, therefill valve 220 is a one-way valve. The refill valve 220 may include afloating check ball. In some examples, the refill valve 220 includes afloating check ball with fluting to increase and/or maximize fluidvelocity across valve. In some examples, the refill valve 220 is alignedwith the fluid reservoir port 214. As shown in FIG. 2B, the fluidreservoir port 214 defines a longitudinal axis 219 and the refill valve220 is aligned along the longitudinal axis 219. For example, in theinflation mode, fluid flows through the refill valve 220 to the pumpbulb 208, and the refill valve 220 is positioned along an axis that isaligned with the longitudinal axis 219 of the fluid reservoir port 214.The refill valve 220 being in-line with the fluid reservoir port 214 mayminimize fluid pathway tortuosity, and may decrease the pressure dropacross the refill valve 220 to increase refill time. In some examples,the refill valve 220 and the anti-auto inflate valve 230 are disposedwithin the same fluid passageway within the valve body 210. In someexamples, the refill valve 220 is aligned with the anti-auto inflatevalve 230. For example, a longitudinal axis of the refill valve 220 maybe substantially aligned with a longitudinal axis of the anti-autoinflate valve 230.

The inflation valve 222 is disposed within a fluid passageway within thevalve body 210 between the main bore 225 and the pump bulb 208. Theinflation valve 222 is used to transfer fluid during the inflation mode,but not used to transfer fluid in the deflation mode. In some examples,the inflation valve 222 is a one-way valve. In some examples, theinflation valve 222 includes a check ball and a biasing member thatbiases the inflation valve 222 to a sealing position. In some examples,the biasing member of the inflation valve 222 is a spring. In someexamples, the size of the check ball of the inflation valve 222 issmaller than the size of the check ball of the refill valve 220. In someexamples, the smaller check ball and relatively light spring of theinflation valve 222 may decrease the squeeze force required to overcomethe spring load.

In the inflation position (as shown in FIG. 2B), the pump bulb 208 isused to transfer fluid from the fluid reservoir to the inflatablemember. For example, the user may depress (or squeeze) the pump bulb 208and then release the pump bulb 208, and then repeat these operationsuntil the desired rigidity is achieved in the inflatable member. Therelease of the pump bulb 208 creates a suction force that pulls fluidfrom the fluid reservoir to the pump bulb 208 as shown by the arrow inFIG. 2B. For example, the fluid flows through the fluid reservoir port214 and through the valve body 210 and into the pump bulb 208. In thevalve body 210, the fluid flows through a fluid passageway that includesthe post area 246 and the refill valve 220. The refill valve 220 beingin-line with the fluid reservoir port 214 may minimize fluid pathwaytortuosity, and may decrease the pressure drop across the refill valve220 to increase refill time. The fluid does not enter the main bore 225when being transferred through the fluid passageway from the fluidreservoir port 214 to the pump bulb 208.

The depression (or squeezing) of the pump bulb 208 expels the fluid fromthe pump bulb 208 to the inflatable member. For example, in the valvebody 210, the fluid flows through the inflation valve 222, into the mainbore 225 (with the movable valve element 240 in the inflation position),and then out of the main bore 225 into the first and second cylinderfluid ports 213, 215. In the inflation position, the movable valveelement 240 blocks a fluid passageway from the main bore 225 to the postarea 246 (e.g., preventing fluid from flowing from the main bore 225 tothe post area 246 during the inflation mode). Rather, the fluid flowsthrough the main bore 225 between the ring member 242 and the end of thecavity of the main bore 225, and into the first and second cylinderfluid ports 213, 215. In some examples, the fluid pathway from the pumpbulb 208 to the first and second cylinder fluid ports 213, 215 maydecrease the pressure drop across the inflation valve 222 to allow forfaster inflate time and may provide less fluid resistance (therebyrequiring less pump bulb squeeze force).

The user may press the movable valve element 240 to move along the axis221 to the deflation position (as shown in FIGS. 2C, 2D, and 2E). Insome examples, the axis 221 is substantially orthogonal (e.g.,perpendicular) to the axis 219. In some examples, a single instantaneouspush of the movable valve element 240 causes the movable valve element240 to move to the deflation position (and stay in the deflationposition). In the deflation position, the edge of the second end portion245 of the movable valve element 240 may be disposed adjacent to (orcontact) a protrusion at the end of the main bore 225 with the biasingmember 244 being in a compressed state. In some examples, due to thepressure inside of the inflatable member, some of the fluid may beautomatically transferred from the inflation member to the fluidreservoir via the pump assembly 206 (bypassing the pump bulb 208), andthen the user may squeeze the inflatable member to transfer some of theremaining fluid in the inflatable member.

Movement of the movable valve element 240 to the deflation positioncauses a fluid passageway to open between the main bore 225 and the postarea 246 (as shown in FIG. 2D), and closes a fluid passageway from themain bore 225 to the inflation valve 222. The fluid may flow from thefirst and second cylinder ports 213, 215 into the main bore 225 (via afluid passageway between the cylinder fluid ports 213, 215 and the mainbore 225), and the movable valve element 240 causes the fluid to flowinto the post area 246. The fluid flows through the anti-auto inflatevalve 230 and into the fluid reservoir port 214 (via a fluid passagewaybetween the post area 246 and the fluid reservoir port 214). In thedeflation mode, the fluid is not routed through the pump bulb 208. Also,in the deflation mode, the refill valve 220 and the inflation valve 222are not used.

FIGS. 3A through 3E illustrate various perspectives of a pump assembly306 having a push valve 324 configured to move from an inflationposition to a deflation position to open a fluid passageway thattransfers fluid from an inflatable member to a fluid reservoir in amanner that bypasses a pump bulb 308. In the inflation position, thepump assembly 306 transfers fluid from the fluid reservoir to theinflatable member via the pump bulb 308. However, in the deflationposition, the pump assembly 306 transfers fluid from the inflatablemember to the fluid reservoir that bypasses the pump bulb 308. In someexamples, the push valve 324 is a push rod valve. In some examples, thepump assembly 306 is an example of the pump assembly 106 of FIG. 1, andmay include any of the features discussed with reference to theinflatable penile prosthesis 100 of FIG. 1 and/or the pump assembly 206of FIGS. 2A through 2E. Also, the pump assembly 106 of FIG. 1 and/or thepump assembly 206 of FIGS. 2A through 2E may include any of the featureswith respect to the pump assembly 306 of FIGS. 3A though 3E.

FIG. 3A illustrates a perspective of an exterior of the pump assembly306 according to an aspect. FIG. 3B illustrates a perspective of thepump assembly 306 with the push valve 324 in the inflation positionaccording to an aspect. FIG. 3C illustrates a perspective of the pumpassembly 306 with the push valve 324 in the deflation position accordingto an aspect. FIG. 3D illustrates a perspective of a valve body 310 ofthe pump assembly 306 with the push valve 324 in the inflation positionaccording to an aspect. FIG. 3E illustrates a perspective of the valvebody 310 with the push valve 324 in the deflation position according toan aspect.

The pump assembly 306 includes the pump bulb 308, the valve body 310,the push valve 324, a button component 312, and fluid transfer portssuch as a first cylinder fluid port 313, a second cylinder fluid port315, and a fluid reservoir port 314. The valve body 310 includespassageways and valve components. The valve body 310 and/or the pumpassembly 306 include the push valve 324, a refill valve 320, and aninflation valve 322. In some examples, the valve body 310 includes ananti-auto inflate area 365 (see FIG. 3C) that includes an anti-autoinflate valve. In some examples, the anti-auto inflate valve includes acheck ball. In some examples, the anti-auto inflate valve includes acheck ball and a biasing member (e.g., a spring).

The push valve 324 includes a movable valve element 340 and a biasingmember 344 that biases the movable valve element 340 to the inflationposition (as shown in FIG. 3B). As shown in FIGS. 3A and 3B, the buttoncomponent 312 may be a flexible button-shaped material that extends overthe movable valve element 340. In some examples, the button component312 may be considered a portion of the valve body's housing extends froma side surface 317 of the valve body 310. In some examples, the biasingmember 344 includes an elastomer control valve spring. In some examples,the biasing member 344 includes a spring. In some examples, the movablevalve element 340 includes an elongated cylindrical valve member. Insome examples, the movable valve element 340 is a push rod havingsections of different sizes. In some examples, the movable valve element340 includes a poppet. In some examples, the movable valve element 340includes a directional control valve.

As shown in greater detail in FIGS. 3D and 3E, the movable valve element340 includes a first end portion 343, a first central portion 347, asecond central portion 349, and a second end portion 345. In someexamples, the first end portion 343 includes a button-shaped end that isslightly smaller than the button component 312 such that the first endportion 343 can fit into the button component 312. The second endportion 345 defines a ring member 342. The ring member 342 may be acircular portion that extends around the end of the movable valveelement 340. In some examples, the ring member 342 includes an annularring. In some examples, the ring member 342 includes a retainer ring.The second central portion 349 has a size (e.g., diameter) that is lessthan a size (e.g., diameter) of the first central portion 347. In someexamples, the first end portion 343 has a size (e.g., diameter) that isless than the size of the second central portion 349. In some examples,the second central portion 349 has a length (e.g., extending along anaxis 321) longer than a length (e.g., extending along the axis 321) ofthe first central portion 347. In some examples, the push valve 324 (orthe valve body 310 in general) includes a single poppet.

The movable valve element 340 (or a portion thereof) is movable within amain bore 325 defined by the valve body 310. For example, in theinflation position, the first end portion 343 of the movable valveelement 340 extends from the side surface 317 (but is covered by thebutton component 312). In some examples, the main bore 325 is acylindrical cavity. The user may press the movable valve element 340 tomove the movable valve element 340 in the main bore 325 along the axis321 to the deflation position (as shown in FIGS. 3C and 3D). In someexamples, the button component 312 then flexes back to its originalshape while the movable valve element 340 remains in the deflationposition. In the deflation position, the ring member 342 on the secondend portion 345 of the movable valve element 340 may be disposedadjacent to the end of the main bore 325 and/or in contact with aportion 362 of the valve body 310 that slightly extends into the mainbore 325. In the deflation position, the biasing member 344 iscompressed. In some examples, in the deflation position, the edge of thefirst end portion 343 of the movable valve element 340 may be disposedwithin the valve body 310 and/or substantially aligned with the sidesurface 317 of the valve body 310.

The pressure in the inflatable member may hold the movable valve element340 in the deflation position (e.g. cylinder pressure seats the pushvalve 324). In some examples, the main bore 325 may include one or moreprotrusions that contact the ring member 342 (and/or another portion ofthe movable valve element 340) to hold the movable valve element 340 inthe deflation position. In some examples, the biasing member 344 isconfigured to return the movable valve element 340 to the inflationposition in response to the cylinder pressure dropping below a thresholdlevel. In some examples, the user may squeeze the pump bulb 308 and theresulting pressure causes the movable valve element 340 to move back tothe inflation position.

The refill valve 320 is disposed in a fluid passageway between the mainbore 325 and the pump bulb 308. The refill valve 320 is used to transferfluid in the inflation mode, but not used to transfer fluid in thedeflation mode. In some examples, the refill valve 320 is a one-wayvalve. The refill valve 320 may include a floating check ball. In someexamples, the refill valve 320 includes a floating check ball withfluting to increase and/or maximize fluid velocity across valve. In someexamples, the refill valve 320 is aligned with the fluid reservoir port314. The fluid reservoir port 314 defines a longitudinal axis 319 andthe refill valve 320 is aligned along the longitudinal axis 319. Forexample, in the inflation mode, fluid flows through the refill valve 320to the pump bulb 308, and the refill valve 320 is positioned along anaxis that is aligned with the longitudinal axis 319 of the fluidreservoir port 314. The refill valve 320 being in-line with the fluidreservoir port 314 may minimize fluid pathway tortuosity, and maydecrease the pressure drop across the refill valve 320 to increaserefill time.

The inflation valve 322 is disposed within a fluid passageway betweenthe main bore 325 and the pump bulb 308. In some examples, the inflationvalve 322 is disposed in a separate fluid passageway than the refillvalve 320. In some examples, the inflation valve 322 and the refillvalve 320 are parallel to each other. The inflation valve 322 is used totransfer fluid during the inflation mode, but not used to transfer fluidin the deflation mode. In some examples, the inflation valve 322 is aone-way valve. In some examples, the inflation valve 322 includes acheck ball and a biasing member that biases the inflation valve 322 to asealing position. In some examples, the biasing member of the inflationvalve 322 is a spring. In some examples, the size of the check ball ofthe inflation valve 322 is smaller than the size of the check ball ofthe refill valve 320. In some examples, the smaller check ball andrelatively light spring of the inflation valve 322 may decrease thesqueeze force required to overcome the spring load.

In the inflation position (as shown in FIGS. 3B and 3D), the pump bulb308 is used to transfer fluid from the fluid reservoir to the inflatablemember. For example, the user may depress (or squeeze) the pump bulb 308and then release the pump bulb 308, and then repeat these operationsuntil the desired rigidity is achieved in the inflatable member. Therelease of the pump bulb 308 creates a suction force that pulls fluidfrom the fluid reservoir to the pump bulb 308 as shown by the arrow inFIG. 3B. For example, the fluid flows through the fluid reservoir port314, through the valve body 310, through the refill valve 320, and intothe pump bulb 308. In the valve body 310, the fluid flows from the fluidreservoir port 314 into a portion 364 of the main bore 325. In theinflation position, the portion 364 of the main bore 325 is a boreportion between the first central portion 347 of the movable valveelement 340 and the ring member 342 of the movable valve element 340. Inthe inflation position, the second central portion 349 (e.g., having thereduced size) of the movable valve element 340 is positioned in the mainbore 325 such that the movable valve element 340 directs the flow offluid around the second central portion 349 and into the fluidpassageway having the refill valve 320.

The depression (or squeezing) of the pump bulb 308 expels the fluid fromthe pump bulb 308 to the inflatable member. For example, the fluid flowsfrom the pump bulb 308, through the inflation valve 322, into a portion366 of the main bore 325, and then into the first and second cylinderfluid ports 313, 315. In the inflation position, the portion 366 of themain bore 325 is a bore portion disposed between the ring member 342 ofthe movable valve element 340 and an end 368 of the main bore 325. Forinstance, in the inflation position, the ring member 342 may separatethe fluid passageway in the main bore 325 from the fluid reservoir port314 to the pump bulb 308 and the fluid passageway in the main bore 325from the pump bulb 308 to the first and second cylinder fluid ports 313,315. In some examples, the fluid pathway from the pump bulb 308 to thefirst and second cylinder fluid ports 313, 315 may decrease the pressuredrop across the inflation valve 322 to allow for faster inflate time andmay provide less fluid resistance (thereby requiring less pump bulbsqueeze force).

The user may press the movable valve element 340 to move along the axis321 to the deflation position (as shown in FIGS. 3C and 3E). In someexamples, the axis 321 is substantially orthogonal (e.g., perpendicular)to the axis 319. In some examples, a single instantaneous push of themovable valve element 340 causes the movable valve element 340 to moveto the deflation position (and stay in the deflation position). In thedeflation position, the biasing member 344 is compressed, and the ringmember 342 contacts a portion 362 of the valve body 310 that extendsinto the main bore 325. In some examples, due to the pressure inside ofthe inflatable member, some of the fluid may be automaticallytransferred from the inflation member to the fluid reservoir via thepump assembly 306 (bypassing the pump bulb 308), and then the user maysqueeze the inflatable member to transfer some of the remaining fluid inthe inflatable member.

Movement of the movable valve element 340 to the deflation positioncloses the fluid passageway in the main bore 325 between the fluidreservoir port 314 and the pump bulb 308 and closes the fluid passagewayin the valve body 310 between the pump bulb 308 and the first and secondcylinder ports 313, 315. As shown in FIG. 3C, in the deflation position,the fluid may flow through a portion of the main bore 325 between thering member 342 and the first central portion 347. In the deflationmode, the fluid is not routed through the pump bulb 308. Also, in thedeflation mode, the refill valve 320 and the inflation valve 322 are notused.

FIGS. 4A through 4C illustrates a push valve 424 according to an aspect.The push valve 424 may be an example of any of the push valves discussedwith reference to the previous figures, and may include any of thefeatures discussed herein. FIG. 4A illustrates a perspective of the pushvalve 424 according to an aspect. FIG. 4B illustrates a perspective ofthe push valve 424 in the inflation position according to an aspect.FIG. 4C illustrates a perspective of the push valve 424 in the deflationposition according to an aspect.

The push valve 424 includes a two-piece movable valve element 440. Themovable valve element 440 includes a first movable member 470 and asecond movable member 472. The first movable member 470 and the secondmovable member 472 are unitary bodies that are separate from each other.The first movable member 470 and the second movable member 472 areconcentrically aligned. The first movable member 470 and the secondmovable member 472 are configured to move independently of each otherwithin a main bore 425 of a valve body 410. The push valve 424 includesa first biasing member 444 that biases the first movable member 470 tothe inflation position, and a second biasing member 445 that biases thesecond movable member 472 to the inflation position. The first biasingmember 444 and the second biasing member 445 are configured to becompressed upon an application of force. In some examples, the firstbiasing member 444 includes a spring having a plurality of coils. Insome examples, the second biasing member 445 includes a spring having aplurality of coils.

The first movable member 470 may be a cylindrical body having sectionswith different sizes (e.g., diameters). The second movable member 472may be a cylindrical body having sections with different sizes (e.g.,diameters). The first movable member 470 includes a ring member 442disposed on one end portion of the first movable member 470 and aninterfacing portion 471 disposed on the other end portion of the firstmovable member 470. The second movable member 472 includes a ring member443 disposed on one end portion of the second movable member 472, aninterfacing portion 473 disposed on the other end portion of the secondmovable member 472, and a ring member 447 disposed on the second movablemember 472 at a location between the interfacing portion 473 and thering member 443. The ring members 442, 443, 447 may be circular portionsthat extend around portions of the first movable member 470 or thesecond movable member 472. In some examples, the ring members 442, 443,447 may be annular rings or retainer rings.

The interfacing portion 471 of the first movable member 470 may bemovably coupled (e.g., contact and slide) with respect to theinterfacing portion 473 of the second movable member 472. In someexamples, the interfacing portion 471 may overlap with the interfacingportion 473 and may move away from each other such that the interfacingportion 471 and the interfacing portion 473 partially overlap (or do notoverlap at all). In some examples, each of the interfacing portion 471and the interfacing portion 473 has a width that is narrower than otherportions of the first movable member 470 and the second movable member472, respectively. In some examples, the first movable member 470defines a channel or groove on a surface portion of the first movablemember 470 that is configured to receive the interfacing portion 473 ofthe second movable member 472, and the second movable member 472 definesa channel or groove on a surface portion of the second movable member472 that is configured to receive the interfacing portion 471 of thefirst movable member 470.

A user may press the button component 412 that causes the first movablemember 470 and the second movable member 472 to linearly move to thedeflation position in which the first biasing member 444 and the secondbiasing member 445 are compressed. The first biasing member 444 isdisposed in the main bore 425, and contacts the ring member 442 on thefirst movable member 470. For example, the first biasing member 444 maybe disposed between the ring member 442 and an end portion 480 of themain bore 425. The ring member 442 defines slots 474 that receive coilportions of the first biasing member 444. For example, the first biasingmember 444 contacts the ring member 442 at the slots 474 to bias thefirst movable member 470 to the inflation position. The second biasingmember 445 is disposed in the main bore 425, and contacts the ringmember 447 on the second movable member 472. For example, the secondbiasing member 445 may be disposed between the ring member 447 and aportion 482 of the valve body 410 in the main bore 425. The secondbiasing member 445 contacts the ring member 447 to bias the secondmovable member 472 to the inflation position. In some examples, the ringmember 447 includes slots that receive coils portions of the secondbiasing member 445.

FIGS. 5A through 5D illustrate various perspectives of a pump assembly506 having a push valve 524 configured to move from an inflationposition to a deflation position to open a fluid passageway thattransfers fluid from an inflatable member to a fluid reservoir in amanner that bypasses a pump bulb 508. In some examples, the push valve524 is a switching valve pump. The pump assembly 506 may include any ofthe features discussed with reference to the inflatable penileprosthesis 100 of FIG. 1, the pump assembly 206 of FIGS. 2A through 2E,the pump assembly 306 of FIGS. 3A through 3D, and/or the push valve 424of FIGS. 4A through 4C. Also, the pump assembly 106 of FIG. 1, the pumpassembly 206 of FIGS. 2A through 2E, the pump assembly 306 of FIGS. 3Athrough 3D, and/or the push valve 424 of FIGS. 4A through 4C may includeany of the features with respect to the pump assembly 506 of FIGS. 5Athough 3D.

FIG. 5A illustrates a perspective of an exterior of the pump assembly506 with the push valve 524 in the deflation position according to anaspect. FIG. 5B illustrates a perspective of the pump assembly 506 withthe push valve 524 in the inflation position according to an aspect.FIG. 5C illustrates a perspective of the pump assembly 506 with the pushvalve 524 in the deflation position according to an aspect. FIG. 5Dillustrates a perspective of a valve body 510 of the pump assembly 506with the push valve 524 in the deflation position according to anaspect.

The pump assembly 506 includes the pump bulb 508, the valve body 510,the push valve 524 movable with respect to the valve body 510, and fluidtransfer ports such as a first cylinder fluid port 513, a secondcylinder fluid port 515, and a fluid reservoir port 514. In someexamples, the pump assembly 506 includes a button component that coversthe push valve 524. The valve body 510 includes passageways and valvecomponents. The valve body 510 includes the push valve 524, a refillvalve 520, an inflation valve 522, and an anti-auto inflate valve 530.

The push valve 524 includes a movable valve element 540 and a biasingmember (not shown) that biases the movable valve element 540 to theinflation position (as shown in FIG. 5B). The push valve 524 may includea valve guide 585. In the inflation position, a portion of the movablevalve element 540 extends from a side surface 517 of the valve body 510.In some examples, the biasing member includes a spring. In someexamples, the movable valve element 540 includes an elongatedcylindrical valve member. In some examples, the movable valve element540 is a push rod having sections of different sizes. In some examples,the movable valve element 540 includes a poppet. In some examples, themovable valve element 540 includes a directional control valve.

The movable valve element 540 includes a first end portion 543, acentral portion 549, and a second end portion 545. In some examples, thecentral portion 549 has a size (e.g., diameter) less than a size (e.g.,diameter) of the first end portion 543 and a size (e.g., diameter) ofthe second end portion 545. In some examples, the first end portion 543includes a ring member. In some examples, the second end portion 545includes a ring member. In some examples, the ring member includes anannular ring or a retainer ring. The central portion 549 has a lengthlonger than a length of the first end portion 543 and longer than alength of the second end portion 545.

In some examples, the pressure in the inflatable member may hold themovable valve element 540 in the deflation position (e.g. cylinderpressure seats the push valve 524). In some examples, the main bore 525may include one or more protrusions that contact one or more portions ofthe movable valve element 540 to hold the movable valve element 540 inthe deflation position. In some examples, the user may squeeze the pumpbulb 508 and the resulting pressure causes the movable valve element 540to move back to the inflation position.

The refill valve 520 is disposed in a fluid passageway between the fluidreservoir port 514 and the pump bulb 508. The refill operation does notpass through the main bore 525 so there may be less fluid resistance inthe refill state. The refill valve 520 is used to transfer fluid in theinflation mode, but not used to transfer fluid in the deflation mode. Insome examples, the refill valve 520 is a one-way valve. The refill valve520 may include a floating check ball. In some examples, the refillvalve 520 includes a floating check ball with fluting to increase and/ormaximize fluid velocity across valve. In some examples, the refill valve520 is aligned with the fluid reservoir port 514. The fluid reservoirport 514 defines a longitudinal axis 519 and the refill valve 520 isaligned along the longitudinal axis 519. For example, in the inflationmode, fluid flows through the refill valve 520 to the pump bulb 508, andthe refill valve 520 is positioned along an axis that is aligned withthe longitudinal axis 519 of the fluid reservoir port 514. The refillvalve 520 being in-line with the fluid reservoir port 514 may minimizefluid pathway tortuosity, and may decrease the pressure drop across therefill valve 520 to increase refill time.

The inflation valve 522 is disposed within a fluid passageway betweenthe main bore 525 and the pump bulb 508. In some examples, the inflationvalve 522 is disposed in a separate fluid passageway than the refillvalve 520. In some examples, the inflation valve 522 and the refillvalve 520 are parallel to each other. The inflation valve 522 is used totransfer fluid during the inflation mode, but not used to transfer fluidin the deflation mode. In some examples, the inflation valve 522 is aone-way valve. In some examples, the inflation valve 522 includes acheck ball and a biasing member that biases the inflation valve 522 to asealing position. In some examples, the biasing member of the inflationvalve 522 is a spring. In some examples, the size of the check ball ofthe inflation valve 522 is smaller than the size of the check ball ofthe refill valve 520. In some examples, the smaller check ball andrelatively light spring of the inflation valve 522 may decrease thesqueeze force required to overcome the spring load.

In the inflation position, the pump bulb 508 is used to transfer fluidfrom the fluid reservoir to the inflatable member. For example, the usermay depress (or squeeze) the pump bulb 508 and then release the pumpbulb 508, and then repeat these operations until the desired rigidity isachieved in the inflatable member. The release of the pump bulb 508creates a suction force that pulls fluid from the fluid reservoir to thepump bulb 308 as shown by the arrow in FIG. 5B. For example, the fluidflows through the fluid reservoir port 514, the refill valve 520, andinto the pump bulb 508.

The depression (or squeezing) of the pump bulb 508 expels the fluid fromthe pump bulb 508 to the inflatable member. For example, the fluid flowsfrom the pump bulb 508, through the inflation valve 522, into a portionof the main bore 525, and then into the first and second cylinder fluidports 513, 515. The second end portion 545 of the movable valve element540 directs the fluid into the first and second cylinder fluid ports513, 515. In some examples, the fluid pathway from the pump bulb 508 tothe first and second cylinder fluid ports 513, 515 may decrease thepressure drop across the inflation valve 522 to allow for faster inflatetime and may provide less fluid resistance (thereby requiring less pumpbulb squeeze force).

The user may press the movable valve element 540 to move along the axis521 to the deflation position. In some examples, the axis 521 issubstantially orthogonal (e.g., perpendicular) to the axis 519. In someexamples, a single instantaneous push of the movable valve element 540moves the movable valve element 540 to the deflation position (and stayin the deflation position). As shown in FIG. 5C, in the deflationposition, the fluid may flow from the first and second cylinder fluidports 513, 515, through the anti-auto inflate valve 530, and into thefluid reservoir port 514. In the deflation mode, the fluid is not routedthrough the pump bulb 508. Also, in the deflation mode, the refill valve520 and the inflation valve 522 are not used.

FIGS. 6A through 6B illustrates various perspectives of a feedbackcomponent 611 configured to provide at least one of tactile or auditoryfeedback in response to moving a movable valve element 640 to thedeflation position. The feedback component 611 is disposed between themovable valve element 640 and a button component 612. The feedbackcomponent 611 may be used in any of the push assemblies discussedherein.

FIG. 6A illustrates the feedback component 611 as a dome structure 685according to an aspect. In some examples, the dome structure 685includes a rounded vault and a circular base. In some examples, when thedome structure 685 is compressed, the dome structure 685 may create asound. In some examples, when the dome structure 685 is compressed, thedome structure 685 may provide a tactile sensation that is perceptibleby the user. FIG. 6B illustrates the feedback component 611 disposed onan end surface 633 of the movable valve element 640 according to anaspect. When the button component 612 is pressed, the button component612 moves the movable valve element 640 in order to place the push valvein the deflation position. The movable valve element 640 and the buttoncomponent 612 compress the feedback component 611, which causes thefeedback component 611 to provide at least one of tactile or auditoryfeedback.

FIG. 7 illustrates a flow chart 700 depicting example operations of amethod of controlling a direction of fluid through a pump assembly of aninflatable penile prosthesis according to an aspect. Although the flowchart 700 is explained with reference to the inflatable penileprosthesis 100 of FIG. 1, the example operations of the flow chart 700may be performed by any of inflatable penile prostheses, pumpassemblies, and/or push valves discussed herein.

Operation 702 includes transferring, by a pump assembly 106, fluid froma fluid reservoir 102 to an inflatable member 104, includingtransferring the fluid from the fluid reservoir 102 to a pump bulb 108via a refill valve 120 and transferring the fluid from the pump bulb 108to the inflatable member 104 via an inflation valve 122 and a push valve124 having a movable valve element 140. Operation 704 includes pushingthe movable valve element 140 along an axis 121 to a deflation positionto change a fluid passageway through a valve body 110 of the pumpassembly 106. Operation 706 includes transferring the fluid from theinflatable member 104 to the fluid reservoir 102 via the push valve 124such that the fluid is not transferred through the pump bulb 108.

FIG. 8 schematically illustrates an inflatable penile prosthesis 800having a pump assembly 806 according to an aspect. The pump assembly 806may include any of the features of the pump assemblies (including thepush valve) described with reference to the previous figures. The penileprosthesis 800 may include a pair of inflatable cylinders 810, and theinflatable cylinders 810 are configured to be implanted in a penis. Forexample, one of the inflatable cylinders 810 may be disposed on one sideof the penis, and the other inflatable cylinder 810 may be disposed onthe other side of the penis. Each inflatable cylinder 810 may include afirst end portion 824, a cavity or inflation chamber 822, and a secondend portion 828 having a rear tip 832.

The pump assembly 806 may be implanted into the patient's scrotum. Apair of conduit connectors 805 may attach the pump assembly 806 to theinflatable cylinders 810 such that the pump assembly 806 is in fluidcommunication with the inflatable cylinders 810. Also, the pump assembly806 may be in fluid communication with a fluid reservoir 802 via aconduit connector 803. The fluid reservoir 802 may be implanted into theuser's abdomen. The inflation chamber or portion 822 of the inflatablecylinder 810 may be disposed within the penis. The first end portion 824of the inflatable cylinder 810 may be at least partially disposed withinthe crown portion of the penis. The second end portion 828 may beimplanted into the patient's pubic region PR with the rear tip 832proximate the pubic bone PB.

In order to implant the inflatable cylinders 810, the surgeon firstprepares the patient. The surgeon often makes an incision in thepenoscrotal region, e.g., where the base of the penis meets with the topof the scrotum. From the penoscrotal incision, the surgeon may dilatethe patient's corpus cavernosae to prepare the patient to receive theinflatable cylinders 810. The corpus cavernosum is one of two parallelcolumns of erectile tissue forming the dorsal part of the body of thepenis, e.g., two slender columns that extend substantially the length ofthe penis. The surgeon will also dilate two regions of the pubic area toprepare the patient to receive the second end portion 828. The surgeonmay measure the length of the corpora cavernosae from the incision andthe dilated region of the pubic area to determine an appropriate size ofthe inflatable cylinders 810 to implant.

After the patient is prepared, the penile prosthesis 800 is implantedinto the patient. The tip of the first end portion 824 of eachinflatable cylinder 810 may be attached to a suture. The other end ofthe suture may be attached to a needle member (e.g., Keith needle). Theneedle member is inserted into the incision and into the dilated corpuscavernosum. The needle member is then forced through the crown of thepenis. The surgeon tugs on the suture to pull the inflatable cylinder810 into the corpus cavernosum. This is done for each inflatablecylinder 810 of the pair. Once the inflation chamber 822 is in place,the surgeon may remove the suture from the tip. The surgeon then insertsthe second end portion 828. The surgeon inserts the rear end of theinflatable cylinder 810 into the incision and forces the second endportion 828 toward the pubic bone PB until each inflatable cylinder 810is in place.

A pump bulb 808 of the pump assembly 806 may be squeezed or depressed bythe user in order to facilitate the transfer of fluid from the fluidreservoir 802 to the inflatable cylinders 810. For example, in theinflation mode, while the user is operating the pump bulb 808, the pumpbulb 808 may receive the fluid from the fluid reservoir 802, and thenoutput the fluid to the inflatable cylinders 810. When the user switchesto the deflation mode, at least some of the fluid can automatically betransferred back to the fluid reservoir 802 (due to the difference inpressure from the inflatable cylinders 810 to the fluid reservoir 802).Then, the user may squeeze the inflatable cylinders 810 to facilitatethe further transfer of fluid through the pump bulb 808 to the fluidreservoir 802.

While certain features of the described implementations have beenillustrated as described herein, many modifications, substitutions,changes and equivalents will now occur to those skilled in the art. Itis, therefore, to be understood that the appended claims are intended tocover all such modifications and changes as fall within the scope of theembodiments.

What is claimed is:
 1. An inflatable penile prosthesis comprising: afluid reservoir configured to hold fluid; an inflatable member; and apump assembly configured to transfer the fluid between the fluidreservoir and the inflatable member, the pump assembly including a pumpbulb, a valve body, a push valve movably coupled to the valve body, afirst fluid port configured to be fluidly coupled to the fluidreservoir, and a second fluid port configured to be fluidly coupled tothe fluid reservoir, the push valve including a movable valve elementconfigured to move between an inflation position and a deflationposition within a bore of the valve body, the movable valve element inthe inflation position defining a fluid passageway through the bore totransfer fluid from the pump bulb to the second fluid port, the movablevalve element, when moved to the deflation position, configured tochange the fluid passageway through the bore to transfer fluid from thesecond fluid port to the first fluid port such that the pump bulb isbypassed.
 2. The inflatable penile prosthesis of claim 1, wherein thepush valve includes a biasing member that biases the movable valveelement to the inflation position.
 3. The inflatable penile prosthesisof claim 1, wherein the push valve includes a poppet having a ringmember.
 4. The inflatable penile prosthesis of claim 1, wherein themovable valve element is configured to move to the deflation position ina linear direction based on a single instantaneous push of the movablevalve element by a user.
 5. The inflatable penile prosthesis of claim 1,wherein the pump assembly includes a button component that encloses aportion of the movable valve element when the movable valve element isin the inflation position.
 6. The inflatable penile prosthesis of claim5, wherein the pump assembly includes a feedback component disposedbetween the button component and the movable valve element, the feedbackcomponent configured to provide at least one of tactile or auditoryfeedback in response to the movable valve element being moved to thedeflation position.
 7. The inflatable penile prosthesis of claim 1,wherein a portion of the movable valve element extends outside the valvebody when the movable valve element is in the inflation position, theportion of the movable valve element being disposed inside the valvebody when the movable valve element is in the deflation position.
 8. Theinflatable penile prosthesis of claim 1, wherein the valve body includesa refill valve aligned with the first fluid port, the refill valveconfigured to transfer fluid from the fluid reservoir to the pump bulbwhen the movable valve element is in the inflation position.
 9. Theinflatable penile prosthesis of claim 1, wherein the valve body includesan inflation valve disposed in a fluid passageway between the pump bulband the bore.
 10. The inflatable penile prosthesis of claim 1, whereinthe movable valve element includes a first movable member and a secondmovable member, the first movable member and the second movable memberconfigured to independently move with respect to each other.
 11. Theinflatable penile prosthesis of claim 1, wherein the valve body includesa refill valve, and an inflation valve, wherein the refill valve and theinflation valve are not used when the movable valve element is in thedeflation position.
 12. A pump assembly for an inflatable penileprosthesis comprising: a push valve movably coupled to a valve body, thepush valve including a movable valve element configured to move betweenan inflation position and a deflation position within a bore of thevalve body; and a plurality of fluid transfer ports including a firstfluid port configured to be fluidly coupled to a fluid reservoir, and asecond fluid port configured to be fluidly coupled to an inflatablemember, the movable valve element in the inflation position defining afluid passageway through the bore to transfer fluid from a pump bulb tothe second fluid port, the movable valve element, when moved to thedeflation position, configured to change the fluid passageway throughthe bore to transfer fluid from the second fluid port to the first fluidport such that the pump bulb is bypassed.
 13. The pump assembly of claim12, wherein the movable valve element includes a cylindrical unitarybody having at least two sections with different diameters.
 14. The pumpassembly of claim 12, wherein the first fluid port includes a firsttubular member, and the second fluid port includes a second tubularmember and a third tubular member, the second tubular member configuredto be fluidly coupled to a first cylinder member of the inflatablemember, the third tubular member configured to be fluidly coupled to asecond cylinder member of the inflatable member.
 15. The pump assemblyof claim 12, further comprising: a refill valve disposed within thevalve body at a location that is aligned with a longitudinal axis of thefirst fluid port; and an inflation valve disposed in a fluid passagewaybetween the bore and the pump bulb.
 16. The pump assembly of claim 12,wherein the movable valve element is configured to move from theinflation position to the deflation position along an axis, the axisbeing substantially orthogonal to the longitudinal axis of the firstfluid port.
 17. The pump assembly of claim 12, further comprising: ananti-auto inflate valve disposed in a fluid passageway between the firstfluid port and the second fluid port.
 18. The pump assembly of claim 12,wherein a portion of the movable valve element extends outside the valvebody when the movable valve element is in the inflation position, thepump assembly further comprising: a button component that encloses theportion of the movable valve element; and a feedback component disposedbetween the button component and an end portion of the movable valveelement, the feedback component configured to provide at least one oftactile or auditory feedback in response to the movable valve elementbeing moved to the deflation position.
 19. A method for controlling adirection of fluid through a pump assembly of an inflatable penileprosthesis, the method comprising: transferring, by a pump assembly,fluid from a fluid reservoir to an inflatable member, including:transferring the fluid from the fluid reservoir to a pump bulb via arefill valve; transferring the fluid from the pump bulb to theinflatable member via an inflation valve and a push valve having amovable valve element; pushing the movable valve element along an axisto a deflation position to change a fluid passageway through a valvebody of the pump assembly; and transferring the fluid from theinflatable member to the fluid reservoir via the push valve such thatthe fluid is not transferred through the pump bulb.
 20. The method ofclaim 19, wherein the refill valve and the inflation valve are not usedto transfer the fluid from the inflation member to the fluid reservoirwhen the movable valve element is in the deflation position.